Veterinary Medicines

Vetoryl 60 mg chewable tablets for dogs

Authorised
  • Trilostane
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Product identification

Medicine name:
Vetoryl 60 mg chewable tablets for dogs
Vetoryl 60 mg žvečljive tablete za pse
Active substance:
  • Trilostane
Target species:
  • Dog
Route of administration:
  • Oral use

Product details

Active substance and strength:
  • Trilostane
    60.00
    milligram(s)
    /
    1.00
    Tablet
Pharmaceutical form:
  • Chewable tablet
Withdrawal period by route of administration:
  • Oral use
    • Dog
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QH02CA01
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Slovenia
Package description:
  • Aluminium – Polyamide/Aluminium/PVC blister.Each blister contains 10 tablets. Cardboard box of 1 blister.
  • Aluminium – Polyamide/Aluminium/PVC blister.Each blister contains 10 tablets. Cardboard box of 3 blisters.
  • Aluminium – Polyamide/Aluminium/PVC blister.Each blister contains 10 tablets. Cardboard box of 5 blisters.
  • Aluminium – Polyamide/Aluminium/PVC blister.Each blister contains 10 tablets. Cardboard box of 6 blisters.
  • Aluminium – Polyamide/Aluminium/PVC blister.Each blister contains 10 tablets. Cardboard box of 10 blisters.

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Full application - known active substance (Article 8 of Regulation (EU) 2019/6)
Marketing authorisation holder:
  • Dechra Regulatory B.V.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Lelypharma B.V.
Responsible authority:
  • Agency For Medicinal Products And Medical Devices Of The Republic Of Slovenia
Authorisation number:
  • MR/V/0606/007
Date of authorisation status change:
Reference member state:
  • Ireland
Procedure number:
  • IE/V/0514/008
Concerned member states:
  • Austria
  • Belgium
  • Croatia
  • Czechia
  • Denmark
  • Finland
  • France
  • Germany
  • Greece
  • Hungary
  • Italy
  • Luxembourg
  • Netherlands
  • Norway
  • Poland
  • Portugal
  • Slovakia
  • Slovenia
  • Spain
  • Sweden
  • United Kingdom (Northern Ireland)

Documents

Summary of Product Characteristics

English (PDF)
Published on: 25/09/2024
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Slovenian (PDF)
Published on: 19/09/2024
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Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Slovenian (PDF)
Published on: 19/09/2024
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Labelling

This document does not exist in this language (English). You can find it in another language below.
Slovenian (PDF)
Published on: 19/09/2024
Download

ie-puar-mr-iev0514008-vetoryl-60-mg-chewable-tablets-for-dogs-en.pdf

English (PDF)
Published on: 25/09/2024
Download
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